Comparative Efficacy of 3L and 2L Integrated Techniques for Gynecologic Cancer-related Lower Extremity Lymphedema: a Retrospective Study

NCT ID: NCT06920732

Last Updated: 2025-04-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 125 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-04-01
• Study Completion Date: 2023-12-31

Brief Summary

The goal of this retrospective study is to evaluate the long-term efficacy of 3L versus 2L integrated techniques in patients with gynecologic cancer-related lower extremity lymphedema (GCR-LEL). The main research question is:

Do 3L integrated techniques provide superior long-term outcomes in reducing lower extremity lymphedema compared to 2L techniques in patients with GCR-LEL?

Medical records of patients who have received either 3L or 2L integrated interventions as part of their routine clinical management for GCR-LEL were reviewed and analyzed to assess treatment outcomes over an extended follow-up period.

Conditions

Gynecologic Cancer-related Lower Extremity Lymphedema; Lymphedema

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

VLNT + LVA + LS (Vascularized Lymph Node Transfer + Lymphaticovenular Anastomosis + Liposuction)

This triple-modality intervention combines physiologic and debulking techniques. VLNT is performed to restore lymphatic function by transferring vascularized lymph nodes to the affected limb. LVA further facilitates lymphatic drainage by creating anastomoses between lymphatic vessels and nearby venules. LS is conducted to remove excess fibroadipose tissue and reduce limb volume. This comprehensive approach is hypothesized to provide synergistic and sustained benefits in severe or refractory lymphedema cases.

VLNT（Vascularized Lymph Node Transfer）

Intervention Type: PROCEDURE

VLNT is a physiologic surgical procedure in which vascularized lymph nodes are harvested from a donor site (e.g., groin or submental region) and transplanted to the affected limb to restore lymphatic drainage. The transferred lymph nodes are anastomosed to recipient vessels to ensure perfusion, aiming to reconstruct lymphatic flow and reduce lymphedema-related swelling and fibrosis.

LVA（Lymphaticovenular Anastomosis）

Intervention Type: PROCEDURE

LVA is a supermicrosurgical technique designed to improve lymphatic drainage by creating anastomoses between functional lymphatic vessels and nearby venules. Under high magnification, lymphatic vessels (typically \<0.8 mm) are identified and connected to subdermal venules to bypass obstructed lymphatic pathways, facilitating improved lymph flow and symptom relief in patients with early-stage lymphedema.

LS（Liposuction）

Intervention Type: PROCEDURE

LS is a volume-reduction procedure used in the management of advanced lymphedema characterized by fibroadipose tissue hypertrophy. Tumescent liposuction is performed to remove excess subcutaneous adipose tissue, thereby reducing limb volume and improving limb contour. This procedure is often combined with physiologic surgical techniques for optimal long-term outcomes.

VLNT + LS (Vascularized Lymph Node Transfer + Liposuction)

This dual-modality intervention focuses on both physiologic restoration and volume reduction. VLNT is used to reconstruct lymphatic drainage pathways, while LS addresses tissue hypertrophy. This combination is selected for patients with poor lymphatic function and substantial limb volume increase, in whom LVA is not feasible due to lack of functional lymphatic vessels.

VLNT（Vascularized Lymph Node Transfer）

Intervention Type: PROCEDURE

VLNT is a physiologic surgical procedure in which vascularized lymph nodes are harvested from a donor site (e.g., groin or submental region) and transplanted to the affected limb to restore lymphatic drainage. The transferred lymph nodes are anastomosed to recipient vessels to ensure perfusion, aiming to reconstruct lymphatic flow and reduce lymphedema-related swelling and fibrosis.

LS（Liposuction）

Intervention Type: PROCEDURE

LS is a volume-reduction procedure used in the management of advanced lymphedema characterized by fibroadipose tissue hypertrophy. Tumescent liposuction is performed to remove excess subcutaneous adipose tissue, thereby reducing limb volume and improving limb contour. This procedure is often combined with physiologic surgical techniques for optimal long-term outcomes.

LVA + LS (Lymphaticovenular Anastomosis + Liposuction)

This approach combines a minimally invasive physiologic procedure (LVA) with LS. LVA promotes lymph flow by bypassing obstructed lymphatic channels, while LS removes accumulated fibrofatty tissue. It is suitable for patients with partially preserved lymphatic function and moderate limb volume increase.

LVA（Lymphaticovenular Anastomosis）

Intervention Type: PROCEDURE

LVA is a supermicrosurgical technique designed to improve lymphatic drainage by creating anastomoses between functional lymphatic vessels and nearby venules. Under high magnification, lymphatic vessels (typically \<0.8 mm) are identified and connected to subdermal venules to bypass obstructed lymphatic pathways, facilitating improved lymph flow and symptom relief in patients with early-stage lymphedema.

LS（Liposuction）

Intervention Type: PROCEDURE

LS is a volume-reduction procedure used in the management of advanced lymphedema characterized by fibroadipose tissue hypertrophy. Tumescent liposuction is performed to remove excess subcutaneous adipose tissue, thereby reducing limb volume and improving limb contour. This procedure is often combined with physiologic surgical techniques for optimal long-term outcomes.

Interventions

VLNT（Vascularized Lymph Node Transfer）

VLNT is a physiologic surgical procedure in which vascularized lymph nodes are harvested from a donor site (e.g., groin or submental region) and transplanted to the affected limb to restore lymphatic drainage. The transferred lymph nodes are anastomosed to recipient vessels to ensure perfusion, aiming to reconstruct lymphatic flow and reduce lymphedema-related swelling and fibrosis.

Intervention Type: PROCEDURE

LVA（Lymphaticovenular Anastomosis）

LVA is a supermicrosurgical technique designed to improve lymphatic drainage by creating anastomoses between functional lymphatic vessels and nearby venules. Under high magnification, lymphatic vessels (typically \<0.8 mm) are identified and connected to subdermal venules to bypass obstructed lymphatic pathways, facilitating improved lymph flow and symptom relief in patients with early-stage lymphedema.

Intervention Type: PROCEDURE

LS（Liposuction）

LS is a volume-reduction procedure used in the management of advanced lymphedema characterized by fibroadipose tissue hypertrophy. Tumescent liposuction is performed to remove excess subcutaneous adipose tissue, thereby reducing limb volume and improving limb contour. This procedure is often combined with physiologic surgical techniques for optimal long-term outcomes.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. The patients diagnosed with gynecological cancer-related lymphedema by clinical examination are classified by the International Lymphedema Society (ISL) guidelines as Stage II to III.

2. .Aged 18-90 years.

Exclusion Criteria

1. Lactation, for patients with pregnancy;

2. Serious heart, lung, liver, kidney disease, as well as the history of tumor patients;

3. Disease history is less than 3 months;

4. In patients with mental illness;

5. Immunodeficiency patients.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Zunyi Medical College

OTHER

Sponsor Role: lead

Responsible Party

Deng Chengliang

Director of the Department of Burn and Plastic Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Burns and Plastic Surgery, Affiliated Hospital of Zunyi Medical University

Zunyi, Guizhou, China

Countries

China

Other Identifiers

KLLY-2024-093

Identifier Type: -

Identifier Source: org_study_id